FDA OKs BRCA Consumer Test

08 March 2018

The company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population. "The test only detects three out of more than 1,000 known BRCA mutations". However, even prescription-ordered genetic testing is not 100% conclusive that a person will develop cancer or not.

Erica Ramos, the organization's president, said, "Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results". They could also face elevated breast cancer risk due to other gene variations or other factors.

The FDA has approved a 23andMe's cancer risk test, one that provides the results directly to the consumer rather than to a doctor who would then provide their patient with info. "But it has a lot of caveats", said Donald St. Pierre, acting director, Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment. About one in 40 individuals of Ashkenazi Jewish descent has one of these three variants. Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn't account for every possible outcome. Additionally, most cases of cancer are not caused by hereditary gene mutations but are thought to be caused by a wide variety of factors, including smoking, obesity, hormone use and other lifestyle issues.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations. The regulator said it reviewed data for the company's test under a pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test. The manufacturer also submitted data on user comprehension, which showed instructions and reports were easily understood.